Clinical Study Start-Up Specialist — Australia (Hybrid)

SmartRecruiters, Inc.; Sydney; Hybrid; AUD 85,000 - 110,000; Full time

Benefits offered by this job

Hybrid work arrangement with WFH days

Onsite parking

Learning and professional development

Mental wellness programs

Novated leasing options

Job summary

PSI is seeking a clinical research professional to support the successful start-up of clinical studies in Australia. You will coordinate site contracts, regulatory documentation, and site activation while collaborating with project teams and investigational sites.

The role emphasizes managing timelines, stakeholder coordination, and TMF maintenance, with a hybrid work arrangement and opportunities for growth within a global CRO.

Qualifications

• Excellent communication skills, both written and verbal.
• Full working proficiency in English.
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Maintain study-specific and startup tracking systems.
• Facilitate site budgets and contract negotiations.
• Support site regulatory document collection.
• Under supervision, prepare submission dossiers to ethics committees.
• Communicate with project team and investigational sites throughout the study lifecycle.
• Develop site startup timelines and enrollment projections; meet site activation milestones.

Skills

Communication skills

English proficiency

MS Office

Education

Bachelor's degree or above

Tools

MS Office

Job description

PSI is seeking a clinical research professional to support the successful start-up of clinical studies in Australia. You will coordinate site contracts, regulatory documentation, and site activation while collaborating with project teams and investigational sites.

The role emphasizes managing timelines, stakeholder coordination, and TMF maintenance, with a hybrid work arrangement and opportunities for growth within a global CRO.